Neurocognitive DisordersPLATANCT05943834
Early Detection of Alzheimer's Disease and Affective Disorders by Automated Voice and Speech Analysis (PLATA)
An observational study of Neurocognitive Disorders, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
Trial summary
PLATA aims to develop an algorithm to identify vocal biomarkers of Alzheimer's dementia. Using data collected as part of routine care, speech patterns will be compared to known biomarkers of Alzheimer's disease, such as amyloid 1-42 and p-Tau in CSF (cerebrospinal fluid). Read more about this study
- Who is it for?
- Ages 50 to 100 years
- Conditions the study is for
- Neurocognitive Disorders
- What is being tested?
- Series of cognitive tasks during a semi-automated call
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 13 Jul 2023to 10 Oct 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants will be recruited through the Memory Clinic at the Geriatric Hospital in Nice (Centre de Mémoire de Ressources et de Recherche, CHU de Nice, Institut Claude Pompidou 10 rue Molière, 06 100 NICE) with a minor or major neurocognitive disorder whose etiology is either: * Probable Alzheimer's disease (positive AD biomarkers) * Mood disorder * Not related to a mood disorder and with negative AD biomarkers
Who may be able to join
- Age ≥ 50 years
- Diagnosis relevant biomarker and neuropsychological data already available
- Cognitively healthy to very mild dementia (CDR score max. 0.5)
- Sufficient knowledge of the study language to understand study information, non opposition form,and questionnaires
- Expression of non opposition
Who cannot join
- Hearing problems
- Patient protected by law, under guardianship or curator ship, or not able to participate in a clinical study according to the article L.1121-16 of the French Public Health Code
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
CHU de Nice
Nice, 06100
Lemaire Justine
Foussat Valérie
About this study
Official title: Early Detection of Alzheimer's Disease and Affective Disorders by Automated Voice and Speech Analysis
PLATA aims to develop an algorithm to identify vocal biomarkers of Alzheimer's dementia.
Using data collected as part of routine care, speech patterns will be compared to known biomarkers of Alzheimer's disease, such as amyloid 1-42 and p-Tau in CSF (cerebrospinal fluid).
If biomarkers of speech can be identified in Alzheimer's disease, it is possible that patients and research participants will no longer need to undergo need to undergo the intensive and invasive baseline biomarker methods currently used, such as lumbar punctures and PET scans.
- Conditions
- Neurocognitive Disorders
- Being tested
- Series of cognitive tasks during a semi-automated call
- Keywords
- Alzheimer's disease, Mood disorder
- Medical subject headings
- Neurocognitive Disorders, Alzheimer Disease, Mood Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Series of cognitive tasks during a semi-automated callOther
Tasks:
- Verbal learning recall (immediate) or Story Recall task (immediate)
- Narrative Storytelling /free speech
- Verbal fluency task
- Verbal learning recall (delayed) or Story Recall task (delayed)
| Study group | Role | What they receive |
|---|---|---|
| Patients with a minor or major neurocognitive disorder | Every patient will receive one semi-automated phone call, during the call a series of cognitive tasks will be performed.
Each task will be recorded in a secondary audio stream which records the participant responses to allow for deep speech analysis of performance on these tasks Receives: Other: Series of cognitive tasks during a semi-automated call |
What is being measured
The primary outcome is the main question the study is designed to answer.
Build and validate speech-based machine learning models for relevant Phenotype detection through access to phenotyped patients from reference memory center.
Speech biomarker algorithm(s)
Measured: 20 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2023
- Study start13 Jul 2023
- Primary completion10 Oct 2027 (estimated)
- Study completion10 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neurocognitive DisordersStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NiceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Eric ETTORE, MD, Principal investigator, Centre Hospitalier Universitaire de Nice
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05943834
- Sponsor's protocol ID
- 23-PP-03
- Acronym
- PLATA
- Status last verified
- Mar 2026
- First submitted
- 5 Jul 2023
- Last updated
- 19 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Detection of Alzheimer's Disease and Affective Disorders by Automated Voice and Speech Analysis
- ClinicalTrials.gov ID
- NCT05943834
- Acronym / sponsor ID
- PLATA / 23-PP-03
- Conditions
- Neurocognitive Disorders
- Keywords
- Alzheimer's disease, Mood disorder
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Study start
- 13 Jul 2023 (actual)
- Primary completion
- 10 Oct 2027 (estimated)
- Study completion
- 10 Oct 2027 (estimated)
- First posted
- 13 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
PLATA aims to develop an algorithm to identify vocal biomarkers of Alzheimer's dementia.
Using data collected as part of routine care, speech patterns will be compared to known biomarkers of Alzheimer's disease, such as amyloid 1-42 and p-Tau in CSF (cerebrospinal fluid).
If biomarkers of speech can be identified in Alzheimer's disease, it is possible that patients and research participants will no longer need to undergo need to undergo the intensive and invasive baseline biomarker methods currently used, such as lumbar punctures and PET scans.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with a minor or major neurocognitive disorder | – | Other: Series of cognitive tasks during a semi-automated callEvery patient will receive one semi-automated phone call, during the call a series of cognitive tasks will be performed. Each task will be recorded in a secondary audio stream which records the participant responses to allow for deep speech analysis of performance on these tasks |
Who may qualify
- Ages
- 50 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants will be recruited through the Memory Clinic at the Geriatric Hospital in Nice (Centre de Mémoire de Ressources et de Recherche, CHU de Nice, Institut Claude Pompidou 10 rue Molière, 06 100 NICE) with a minor or major neurocognitive disorder whose etiology is either: * Probable Alzheimer's disease (positive AD biomarkers) * Mood disorder * Not related to a mood disorder and with negative AD biomarkers
Key inclusion criteria (5 listed)
- Age ≥ 50 years
- Diagnosis relevant biomarker and neuropsychological data already available
- Cognitively healthy to very mild dementia (CDR score max. 0.5)
- Sufficient knowledge of the study language to understand study information, non opposition form,and questionnaires
- Expression of non opposition
Key exclusion criteria (2 listed)
- Hearing problems
- Patient protected by law, under guardianship or curator ship, or not able to participate in a clinical study according to the article L.1121-16 of the French Public Health Code
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Series of cognitive tasks during a semi-automated callTasks: * Verbal learning recall (immediate) or Story Recall task (immediate) * Narrative Storytelling /free speech * Verbal fluency task * Verbal learning recall (delayed) or Story Recall task (delayed) | Other | Patients with a minor or major neurocognitive disorder |
Primary outcome
Build and validate speech-based machine learning models for relevant Phenotype detection through access to phenotyped patients from reference memory center.
Time frame: 20 minutes
Speech biomarker algorithm(s)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Eric ETTORE, MD principal investigator
Centre Hospitalier Universitaire de Nice
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neurocognitive Disorders, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Eric ETTORE, MD (04.92.03.47.70, ettore.e@chu-nice.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Build and validate speech-based machine learning models for relevant Phenotype detection through access to phenotyped patients from reference memory center. (time frame: 20 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2026.